ANDA Litigation Settlements

All claims and counterclaims are dropped concerning Mylan’s alleged infringement of the patents-in-suit.

Mylan will launch one, two, and three mg versions of its generic product in May 2021, two and one-half months prior to the pediatric exclusivity term awarded to the ’673 patent, or earlier under certain unspecified conditions.

Sunovion Pharma. Inc. v. Teva Pharma. USA Inc., 09-1302 (D.N.J.)

Lunesta® (eszopiclone)

6,319,926

6,444,673

6,864,257

7,381,724

Sun Pharma agrees not ot manufacture, use, or offer to sell in the U.S. its generic product until April 15, 2014, or an earlier date that may be permitted by the settlement agreement.

Sun Pharma admits that its ANDA infringes the patents-in-suit.

Medicis Pharma. Corp. v. Actavis Mid Atlantic LLC, 11-0409 (D. Del.)

Medicis Pharma. Corp. v. Actavis Mid Atlantic LLC, 12-1091 (D. Del.)

Ziana® (clindamycin phosphate / tretinoin)

Zyclara® (imiquimod)

6,387,383

RE41,134

8,236,816

Actavis will be allowed to launch its generic Ziana product in July 2016.

Actavis will be allowed to launch its generic Zyclara product in early 2019, or earlier under certain unspecified circumstances.

Valeant, Medicis’ owner, will receive a portion of the sales from each of the two generic products.

AstraZeneca Pharma. LP v. Lupin Ltd., 12-6888 (D.N.J.)

Seroquel XR® (quetiapine fumarate)

5,948,437

Lupin agrees not to make or sell its generic product before November 2016.

Lupin admits that the ’437 patent is enforceable and valid.

Shire LLC v. Sandoz Inc., 11-1110 (D. Colo.)

Intuniv® (guanfacine)

5,854,290

6,287,599

6,811,794

Sandoz agreed to license the patents-in-suit and acknowledged that it would be infringing them in the absence of a licensing agreement.

Shire LLC v. Teva Pharma. USA Inc., 10-0329 (D. Del.)

Intuniv® (guanfacine)

6,287,599

6,811,794

Actavis and Watson acknowledge that their generic products infringe the patents-in-suit and that those patents are valid and enforceable.

Actavis will receive a license to market its generic product beginning December 1, 2013.

Actavis shall retain exclusive right to market its product for the first 180 days of that licensing period but will pay Shire a quarter of the profits it earns during the exclusivity period.

Watson will receive a license to market its generic product after the expiration of Actavis’ exclusivity period.

Purdue Pharma to grant Actavis license to market a specified number of bottles of its generic product in 2014, pending approval of Actavis’ ANDA.

If Actavis does not receive FDA approval prior to Sept. 1, 2014, it would be allowed to launch a specified amount of the generic product beginning in October 2014.

Teva Neuroscience Inc. v. Watson Labs. Inc., 10-5078 (D.N.J.)

Azilect® (rasagiline)

5,453,466

N/A

In re: Oxycontin Antitrust Litigation, 04-1603 (S.D.N.Y.)

OxyContin® (oxycodone hydrochloride)

5,508,042

7,674,799

7,674,800

7,683,072

N/A

Galderma Labs. LP v. Par Pharma., Inc., 12-2563 (N.D. Tex.)

Epiduo® Gel (adapalene / benzoyl peroxide)

8,071,644

8,080,537

8,129,362

N/A

Shire LLC v. Teva Pharma. USA Inc., 10-0329 (D. Del.)

Intuniv® (guanfacine)

6,287,599

6,811,794

Teva was granted a license to market either its own form of Intuniv or authorized generics made by Shire as of 2015.

Teva acknowledges that Shire’s patents are valid and, without a license, Teva’s generic product would infringe the patents.

Merck Sharp & Dohme Corp v. Teva Pharma. USA Inc., 13-1851 (S.D.N.Y.)

Atripla® (efavirenz / emtricitabine / tenofovir disoproxil fumarate)

6,639,071

6,939,964

N/A

Altana Pharma AG v. Teva Pharma. USA Inc., 04-2355 (D.N.J.)

Protonix® (pantoprazole sodium delayed-release tablets)

4,758,579

Teva will pay Pfizer and licensing partner Takeda $1.6 billion.

Sun will pay Pfizer and Takeda $550 million.

Teva and Sun admit that their generic products infringe the patent-in-suit

Shire LLC v. Impac Labs., Inc., 10-5467 (N.D. Cal.)

Intuniv® (guanfacine extended-release tablets)

5,854,290

6,287,599

6,811,794

Shire dropped its infringement claim.

Impax agreed to pay licensing fees and not to challenge the validity of Shire’s patents covering Intuniv.

Hoffman-La Roche Inc. v. Accord Healthcare Inc., 11-3663 (D.N.J.)

Xeloda® (capecitabine tablets)

5,472,949

N/A

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